Demo

Process Engineer

Flambeau Medical
Phoenix, AZ Full Time
POSTED ON 3/6/2025
AVAILABLE BEFORE 6/6/2025

Job Description

Job Description

Position : Process Engineer

About Cinova Medical :

Cinova Medical is a full-service, contract manufacturing organization serving the medical device and life Sciences industries. Each member of our executive leadership team has over 25 years serving in the industry. We provide a full suite of development and manufacturing capabilities in our FDA registered and ISO-13485 : 2016 certified manufacturing operations located in Phoenix, Arizona. Cinova Medical produces medium-to-high volume molded components, secondary operations, fully automated assemblies, Class ll finished device manufacturing, and sterile barrier packaging in our Class 7 & Class 8 clean rooms. We proudly serve many of the world’s leading medical device manufacturing companies.

If you’re good at what you do, you can work anywhere. If you’re the best at what you do, come work at our company.” We are committed to growing the capabilities of our people.

Summary :

Responsible for developing manufacturing processes for plastic injection molded components. The engineer will develop processes by establishing injection molded cycles of new and existing molds. The engineer will also define pre and post molded processes to optimize efficiencies, yields and productivity. The engineer will use process capability studies and other statistical techniques for defining process capability, identifying and eliminating sources of process variability. This individual will provide engineering support to production by troubleshooting injection molding processes and tooling, and by defining mold maintenance requirements. This individual will be responsible for providing customer support for new product development and resolving any quality problems with components.

Responsible for creating and promoting all internal and external ECO’s and ECN’s by using ERP system

Essential Duties and Responsibilities :

  • Develop programs and / or methods to optimize productivity and reduce cycle time, manufacturing losses, and overall costs
  • Develop and execute project plans. Develop documentation for each project and work with associated plant personnel to implement it
  • Establish process development technical guidelines
  • Maintain all BOM’s updated on a daily, weekly, monthly basis
  • Quote existing part numbers after making sure the BOM’s have been updated to reflect the correct sell price
  • Ensure that manufacturing requirements are properly developed and documented in conjunction with appropriate manufacturing, production, and engineering personnel
  • Assure that the process of product adheres to ISO 13485 standards
  • Continuously improve existing processes using design of experiments and other methods to increase efficiencies
  • Support the product development process by assisting the program teams as necessary to ensure successful product launches
  • Provide information and technical assistance to manufacturing, engineering, and production personnel as required
  • Implement Process Control and Process Discipline systems into manufacturing operations
  • Mold validation process set-up, troubleshooting and process monitoring
  • Quotes, procures, modifies and validates both new and existing production mold tooling
  • Resolves technical tooling and process problems associated with both new and old tooling
  • Assists in selection of tooling vendors
  • Directs vendor interface, coordinates in-process changes and approves tooling upon completion
  • Works with our vendors to perform new or modified component validations as applicable; determines the requirements and directs any tooling upgrades to existing tooling
  • Monitors all molding operations, tracking efficiency and potential issues
  • Scientific approach to problem solving machine issues. Tracks statistical data and utilizes SPC to continuously monitor and improve the efficiency of the molding operations
  • Participates in variation scrap and cost reduction opportunities
  • Works as a cross-functional team member with involvement in processes, various designs, troubleshooting, project management and cost analysis
  • Assists in the collection of information, selection and implementation of new molding projects
  • Creates procedures, routings and BOM’s. Assists with corrective actions to resolve non-conformances as root causes are identified
  • Optimize manufacturing practices
  • Improve workforce by training Process Technicians and Mold Technicians on machine efficiency
  • Processing techniques as well as other data-based methods of decision making
  • Other projects and tasks as assigned

Qualifications :

  • Excellent project management skills, including managing multiple projects simultaneously
  • Position requires six years of experience in high volume injection molding environment, design, qualification, validation, building of molds, etc.
  • 3D modeling intermediate level, capable to design fixtures and mold components
  • Strong injection molding experience in troubleshooting, optimizing processes and mold sampling
  • Knowledge of part and mold design, mold fabrication and plastic resins
  • Working knowledge of SPC, TQM, JIT and DFM principles
  • Proficiency with IQMS and MS Office software suites (Word, Excel, Outlook, etc.)
  • Excellent communication and record-keeping skills
  • Education / Experience :

    BS Degree in engineering or 5 years of experience as a Master Molder preferred

    Language Ability :

    Ability to read, write, understand and follow instructions in the English language.

    Effective oral and written communication in the English language.

    Certificates and Licenses :

    Master Molder

    Supervisory Responsibilities :

    None

    Work Environment :

  • The worker is subject to hazards : Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on high places, exposure to high heat or exposure to chemicals
  • The worker is subject to atmospheric conditions : One or more of the following conditions that affect the respiratory system of the skin : Fumes, odors, dusts, mists, gases or poor ventilation
  • The worker is subject to oils : There is air and / or skin exposure to oils and other cutting fluids
  • The worker is subject to vibration : Exposure to oscillating movements of the extremities or whole body
  • Physical Demands :

  • Sedentary Work – Exerting up to 10 pounds of force occasionally and / or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
  • Light Work – Exerting up to 20 pounds of force occasionally, and / or up to 10 pounds of force frequently, and / or lift, carry, push, pull or otherwise move objects. If the use of arm and / or leg controls requires exertion of force greater than sedentary work and worker sits most of the time, the job is light work.
  • Medium Work - Exerting up to 50 pounds of force occasionally, and / or up to 20 pounds of force frequently, and / or up to 10 pounds of force constantly to move objects.
  • Heavy Work - Exerting up to 100 pounds of force occasionally, and / or up to 50 pounds of force frequently, and / or up to 20 pounds of force constantly to move objects.
  • Very Heavy Work - Exerting up to 100 pounds of force occasionally, and / or up to 50 pounds of force frequently, and / or up to 20 pounds of force constantly to move objects.
  • Visual Acuity :

  • The worker is required to have close visual acuity to perform an activity such as; preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and or operation or machines (including inspection); using measurement devices; and / or assembly or fabrication of parts at distance close to the eyes.
  • The worker is required to have visual acuity to perform an activity such as; operating machines where the seeing job is at or within arm’s reach; performing mechanical or skilled trades tasks of a non-repetitive nature such as ones by technicians, etc.
  • The worker is required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.
  • Job Type : Full-time

    Benefits : Medical; Dental; Vision; Life; STD; LTD; 401(k) with company match; Paid Time Off

    Out of state candidates are encouraged to apply. Cinova Medical will provide RELOCATION BONUS.

    Work in a place where your team values you.” Experience what being a part of the Cinova Medical family feels like. Be inspired by your leaders and be encouraged and cheered on by your teammates.

    Cinova Medical, Inc. is an EOE AA M / F / Vet / Disability Employer and Drug Free Workplace.

    Upon hire, Cinova Medical, Inc. uses E-Verify to verify employment eligibility for roles based in the United States.

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